ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) by is a Prescription medication manufactured, distributed, or labeled by Fenwal, Inc., Fenwal International. Drug facts, warnings, and ingredients follow.
Rx only
Contains Y-Sampling Site for the collection of unanticoagulated whole blood samples for laboratory testing and the DONORCARE™ Needle Guard
Use aseptic technique.
Note: Nominal tubing dimensions of product are 0.118" inner diameter x 0.025" wall thickness.
Note: If the Y-Sampling Site is not used, donor samples may be collected using an alternate method following standard procedures.
Precautions:
Note: In difficult collection conditions (e.g. slow blood flow or fine veins), leave the needle guard disengaged behind the hub during collection. Engage the needle guard at the end of blood collection.
Precaution: Do not proceed with the remaining steps until the entire whole blood unit is collected.
Precaution: Complete steps 13 - 21 within approximately 4 minutes after sealing the donor tubing to avoid possible clot formation in the tubing.
Note: If the access device is assembled such that the outer barrel is screwed onto the Luer, make sure to rotate clockwise upon insertion to avoid barrel detaching from Luer.
Notes:
Precaution: When replacing the access device, be careful to avoid contact with any blood droplets on the Luer or Sampling Site. Discard used access device appropriately.
Precaution: The needle guard must be held stationary while the needle is withdrawn into it.
Note: Step 23 may be performed prior to step 21or 22 if desired.
Store at Controlled Room Temperature.
USP Definition of “Controlled Room Temperature”
United States Pharmacopeia, General Notices.
United States Pharmacopeial Convention, Inc.
12601 Twinbrook Parkway, Rockville, MD
Fenwal, Inc.
Lake Zurich, IL 60047 USA
1-800-933-6925
Made in USA
07-19-07-484 REV: A
09/2012
FENWAL, BLOOD-PACK, ADSOL and TRANSFER-PACK are trademarks of Fenwal, Inc.
DONORCARE is a trademark of ITL Corporation.
Manufacturer
© 2012 Fenwal, Inc. All rights reserved.
Code 4R3459
15 Units
Fenwal™
Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK™ Unit; TRANSFER-PACK™ Container with ADSOL™ Red Cell Preservation Solution
Triple For the Collection and Processing of 500 mL Blood
Y-Sampling Site, DONORCARE™ Needle Guard, 16 ga. Ultra Thin Wall Needle
Rx only
Each unit consists of a PL 146 Plastic primary container with 70 mL of CPD solution containing 1.84 g Sodium Citrate (dihydrate) USP, 1.78 g Dextrose (monohydrate) USP, 209 mg Citric Acid (anhydrous) USP, 155 mg Monobasic Sodium Phosphate (monohydrate) USP, pH may have been adjusted with sodium hydroxide; one 400 mL PL 2209 Plastic TRANSFER-PACK container with 110 mL of ADSOL Red Cell Preservation Solution containing 2.42 g Dextrose (monohydrate) USP, 990 mg Sodium Chloride USP, 825 mg Mannitol USP, 30 mg Adenine USP; one empty 400 mL PL 2209 Plastic TRANSFER-PACK container.
Sterile, non-pyrogenic fluid path.
See instructions for use.
Store at Controlled Room Temperature (refer to direction insert).
FENWAL, BLOOD-PACK, ADSOL and TRANSFER-PACK are trademarks of Fenwal, Inc.
DONORCARE is a trademark of ITL Corporation.
Fenwal, Inc.
Lake Zurich, IL 60047 USA
Made in USA
07-28-05-611 REV: A
ADSOL RED CELL PRESERVATION SOLUTION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC)
anticoagulant citrate phosphate dextrose (cpd) solution and adsol preservation solution kit |
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Labeler - Fenwal, Inc. (794519020) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Fenwal International, Inc. | 091164590 | MANUFACTURE(0942-6445) |